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Uterine Flora During Elective and Urgent Cesarean Sections

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00500019
First received: July 11, 2007
Last updated: March 30, 2009
Last verified: March 2009
History of Changes
  Purpose

Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.


Condition
Endometritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • To compare bacteriological growth between elective and non-elective cesarean section [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Uterine bacteriological cultures


Estimated Enrollment: 600
Study Start Date: January 2005
Study Completion Date: September 2008
Groups/Cohorts
1.
Elective Cesarean sections
2.
Non-elective cesarean section

Detailed Description:

Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.

Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing cesarean sections in Western galilee Hospital

Criteria

Inclusion Criteria:

  • Cesarean delivery

Exclusion Criteria:

  • Vaginal delivery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500019

Locations
Israel
Western Galilee Hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Ido Solt, MD Western Galilee Hospital
  More Information

No publications provided

Responsible Party: Professor Jacob Bornstein, Department Obstetrics & Gynecology, Western Galilee Hospital, Nahariya, Israel
ClinicalTrials.gov Identifier: NCT00500019     History of Changes
Other Study ID Numbers: 1-Bornstein
Study First Received: July 11, 2007
Last Updated: March 30, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases

ClinicalTrials.gov processed this record on May 16, 2013